流式细胞术临床检验质量控制专家共识  

Expert consensus on quality management in flow cytometry for clinical laboratories

作　　者：中国中西医结合学会检验医学专业委员会 杨再林 武坤[3] 杨曦明[4] 刘耀 陈双 陈炜烨[5] 程沈菊 龚容[3] 蒋亭亭 李轶勋[3] 林灿 唐鑫怡 王卉 吴丽娟 赵明宇 Laboratory Medicine Committee of the Chinese Association of Integrative Medicine;Yang Zailin;Wu Kun;Yang Ximing;Liu Yao

机构地区：[1]不详 [2]重庆大学附属肿瘤医院血液肿瘤中心 [3]昆明医科大学第一附属医院医学检验科 [4]北京中医药大学东直门医院检验病理科 [5]广东省中医院检验科 [6]河北燕达陆道培医院检验科 [7]西部战区总医院实验室医学中心

出　　处：《中华检验医学杂志》2025年第3期319-330,共12页Chinese Journal of Laboratory Medicine

基　　金：重庆市技术创新与应用发展重点项目(CSTB2024TIAD-KPX0031);重庆市科卫联合医学科研重大项目(2025DBXM002);云南省科技厅科技计划(202201AY070001-058)。

摘　　要：流式细胞术已经广泛应用于临床检验工作中。其质量控制涉及实验室的规范化管理、仪器操作、质量管理活动的开展等多个方面。然而,临床应用中仍面临实验室间的质量管理规范和操作标准尚未完全统一、流式细胞仪器操作及数据分析复杂导致结果易受人为因素影响、如何保证无室间质评检验项目结果的准确性等问题。为此,中国中西医结合学会检验医学专业委员会组织专家,结合国内外相关指南与行业标准,从人员与空间管理、标本管理、试剂与耗材管理、仪器管理、项目管理、室内与室间质量控制等方面对流式细胞术临床检验的质量控制进行了系统的规范,以期为流式细胞术临床检验规范化操作及应用提供指导。Flow cytometry(FCM)has been widely applied in clinical laboratory testing,with its quality control covering multiple aspects,including standardized laboratory management,instrument operation,and the implementation of quality control activities.However,several challenges remain in clinical applications,such as the lack of standardized quality management protocols and operational procedures across laboratories,the complexity of FCM instrument operation and data analysis,which makes results susceptible to human error,and the difficulty in ensuring the accuracy of test results for assays without inter-laboratory proficiency testing.To address these issues,the Laboratory Medicine Committee of the Chinese Association of Integrative Medicine(LMC-CAIM),along with other expert,has developed systematic quality control guidelines for clinical FCM.This guideline,based on relevant domestic and international standards and industry practices,provide comprehensive regulations covering personnel and space management,specimen management,reagent and consumable management,instrument management,test parameter management,and both internal and inter-laboratory quality control.The aim is to standardize clinical FCM practices and optimize its clinical applications.

关 键 词：流式细胞术 临床检验 质量控制 

分 类 号：R446[医药卫生—诊断学] R446.1[医药卫生—临床医学]